Fluticasone Propionate
These highlights do not include all the information needed to use FLUTICASONE propionate safely and effectively. See full prescribing information for FLUTICASONE propionate. FLUTICASONE propionate nasal spray, USP, 50 mcg FOR INTRANASAL USE Initial U.S. Approval: 1994
Approved
Approval ID
13f0f08b-8310-2949-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2015
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluticasone Propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-653
Application NumberANDA077538
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateApril 17, 2015
FDA Product Classification
INGREDIENTS (8)
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT